Nasal devices with noise-reduction and methods of use

ABSTRACT

Described herein are nose-reduced nasal devices configured to reduce or eliminate the unwanted noises associated with use of a nasal device. These noise-reduced nasal devices include a flap-valve airflow resistor and a noise-reduction feature that is a noise-reduction element, a noise-reduction flap valve, or both. The noise-reduction feature typically prevents the flap valve from oscillating or vibrating and producing an audible sound during use, particularly during inhalation through the device. The method and devices described herein may prevent the flap, and particularly the edge region of the flap face or tip of the flap, from oscillating during inhalation.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional patent applicationSer. No. 61/037,180, titled “NASAL DEVICES WITH NOISE-REDUCTION ANDMETHODS OF USE”, filed on Mar. 17, 2008. This application is hereinincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

Nasal respiratory devices may be worn to treat many medical conditions,such as sleep disordered breathing (including snoring, sleep apnea,etc.), Cheyne Stokes breathing, UARS, COPD, hypertension, asthma, GERD,heart failure, and other respiratory and sleep conditions. Devices thatprovide a greater resistance to exhalation than to inhalation may beparticularly useful, and may be worn by a subject when the subject iseither awake or asleep. Indeed, many subjects may apply a nasal devicebefore falling to sleep, so that the device may provide therapeuticbenefits during sleep. However, these devices may produce noise duringoperation that some users (or their bedmates) may find annoying. Forexample, a nasal device including one or more flap valves may produce abuzzing, whistling, or other audible noise or vibration. In the worstcase, the noise may disrupt the sleep of the user or others nearby.Thus, there is a need for noise-reduced (or “quiet”) nasal devices whichmay be worn by a subject during sleep.

Examples of nasal respiratory devices have been well-described in thefollowing US patents and patent applications, each of which isincorporated herein in its entirety: U.S. patent application Ser. No.11/298,640 (titled “NASAL RESPIRATORY DEVICES”) filed Dec. 8, 2005; U.S.patent Ser. No. 11/298,339 (titled “RESPIRATORY DEVICES”) filed Dec. 8,2005; U.S. patent application Ser. No. 11/298,362 (titled “METHODS OFTREATING RESPIRATORY DISORDERS”) filed Dec. 8, 2005; U.S. patentapplication Ser. No. 11/805,496 (titled “NASAL RESPIRATORY DEVICES”)filed May 22, 2007; U.S. Pat. No. 7,506,649 (titled “NASAL DEVICES”)filed Jun. 7, 2007; U.S. patent application Ser. No. 11/759,916 (titled“LAYERED NASAL DEVICES”) filed Jun. 7, 2007; U.S. patent applicationSer. No. 11/811,401 (titled “NASAL RESPIRATORY DEVICES FOR POSITIVEEND-EXPIRATORY PRESSURE”) filed Jun. 7, 2007; U.S. patent applicationSer. No. 11/941,915 (titled “ADJUSTABLE NASAL DEVICES”) filed Nov. 19,2007; and U.S. patent application Ser. No. 11/941,913 (titled “NASALDEVICE APPLICATORS”) filed Nov. 16, 2007.

These nasal respiratory devices are adapted to be removably secured incommunication with a nasal cavity, and may include a passageway (whichmay just be an opening) through the device, a valve (or airflowresistor) in communication with the passageway, and a holdfast. Theholdfast is configured to removably secure the respiratory device atleast partly within (and/or at least partly over and/or at least partlyaround) the nasal cavity. The airflow resistor (which may be a valve) istypically configured to provide greater resistance during exhalationthan during inhalation.

Examples of these devices are shown in FIGS. 1A-2B, and are brieflydescribed below. Exemplary nasal devices may include an airflow resistor(e.g., a flap valve or multiple flap valves) providing a greaterresistance to exhalation than to inhalation, a holdfast to secure thenasal device in communication with the subject's nose, and optionally arim body forming a passageway in which the airflow resistor ispositioned, and an aligner for aligning the device with respect to oneor more of the subject's nostrils. In general, these nasal respiratorydevices may be configured so that the airflow resistor provides aresistance to exhalation that is between about 10 cm H₂O*sec/L and about250 cm H₂O*sec/L (e.g., 0.01 and about 0.25 cm H₂O/(ml/sec)) whenmeasured at 100 ml/sec, and a resistance to inhalation that is betweenabout 0.1 cm H₂O*sec/L and about 20 cm H₂O*sec/L (e.g., 0.0001 and about0.02 cm H₂O/(ml/sec)) when measured at 100 ml/sec. For example, FIGS. 1Aand 1B show front and back perspective views (respectively) of onevariation of an adhesive nasal device.

The nasal device shown in FIGS. 1A and 1B are two single-nostril devicesthat have been joined to form a single device. In similar variations thetwo single-nostril devices are not joined by this bridge region 112, butare kept separate, and may be applied separately to each nostril. Thefront view of the nasal device shown in FIG. 1A illustrates theoutward-facing side of this variation of a nasal device, when it is wornby a subject.

FIGS. 1A-2B show examples of nasal devices that may be adapted toinclude one or more noise-reducing features as described herein. Theresulting noise-reduced nasal device may address the problems identifiedabove. Nasal devices configured to include noise-reduction features tohelp eliminate or reduce unwanted noise are described and illustratedbelow, along with methods of using and methods of forming such devices.

SUMMARY OF THE INVENTION

Described herein are noise-reduced nasal respiratory devices configuredto reduce or eliminate unwanted buzzing, whistling or other noisesassociated with use of a nasal device. In general, noise-reduced (ornoise-reducing) nasal devices are nasal devices having flap-valveairflow resistors that also include a noise-reduction feature such as anoise-reduction element, or a noise-reduction flap valve, or both. Thesenoise-reduction features reduce whistling, rushing or turbulent soundsof air flowing through or around the airflow resistor, and may alsoreduce the sound of the flap valve opening/closing. For example,noise-reduced nasal devices may prevent the free end of the flap valvefrom oscillating or vibrating and producing an audible sound during use.In some variations the flap valve is a noise-reduction flap valve thatprevents the free edge region of the flap face of the flap valve fromorienting in parallel with the direction of airflow through the flapvalve during inhalation. In some variations the device includes anoise-reduction element that controls or limits the oscillation of theflap, particularly the free edge region of the flap face and/or the tipof the flap during inhalation. The noise-reduction element may prevent afree edge region of a face of the flap valve from becoming orientedsubstantially in parallel with the direction of airflow through theopening during inhalation. As used herein, the “edge region of the flapface” typically refers to the region of the flap valve face near thefree edge of the flap valve. As described in greater detail below, aflap valve is generally a flat structure having two opposing faces and aminimal thickness.

A noise-reduced airflow resistor is typically an airflow resistor havinga flap valve that is adapted in some manner to reduce the noisesassociated with the operation of the nasal device during respiration. Anoise-reduced airflow resistor may also be referred to as anoise-reducing or noise-reduction airflow resistor. A noise-reducedairflow resistor may also be referred to as simply herein as an “airflowresistor.” The noise-reduced airflow resistors described hereintypically increase the resistance to expiration more than the resistanceto exhalation. For example, any of the noise-reduced airflow resistorsdescribed herein may be configured to provide the nasal device with aresistance to exhalation that is between about 0.01 and about 0.25 cmH₂O/(ml/sec) when measured at 100 ml/sec, and a resistance to inhalationthat is less than the resistance to exhalation, and may be between about0.0001 and about 0.02 cm H₂O/(ml/sec) when measured at 100 ml/sec. Thesenasal devices may also have one or more leak pathways that areconfigured to remain open during both inhalation and exhalation. Duringoperation of the nasal devices described herein, the flap valve(s) ofthe airflow resistor are typically at least partially closed duringexhalation, increasing the resistance within the target range, and theflap valve(s) of the airflow resistor are typically at least partly openduring inhalation.

Thus, a noise-reduced nasal respiratory device may include anoise-reduced airflow resistor comprising a flap valve, wherein thenoise-reduced airflow resistor is configured to inhibit exhalation morethan inhalation, and to inhibit oscillation of a free edge of the flapvalve during inhalation when the flow rate is between about 20 and 750ml/sec. The noise-reduced nasal respiratory device may also include aholdfast configured to secure the noise-reduced nasal respiratory devicein communication with the subject's nasal cavity. Any appropriateholdfast may be used, including adhesive holdfasts and compressibleholdfasts.

As mentioned, the noise-reduced airflow resistor typically includes oneor more noise-reduction feature such as a noise-reduction flap valve ora noise-reduction element that acts on the flap valve (or both). Forexample, a nose-reduction flap valve may be a flap valve that isstructurally adapted to prevent the edge of the flap valve fromoscillating (e.g., vibrating) at flow rates present during inhalationand/or exhalation. In some variations a noise-reducing flap valve isadapted by having a thickness and/or durometer that is sufficient toprevent oscillation while allowing operation of the flap valve over adesired range of exhalation and/or inhalation resistances. In somevariations the flap valve is configured to have an open configurationthat prevents noise.

A noise-reducing element may be used with a flap valve (including butnot limited to noise-reducing flap valves) to reduce or preventvibration or oscillation of the flap valve (and particularly the edge ofthe flap valve). As used herein, the phrase “oscillation” typicallyrefers to vibration of all or a portion of the flap valve that mayresult in an audible sound (such as a buzzing). Any of the noise-reducednasal respiratory devices described herein may include either anoise-reducing element (e.g., an element that acts on the flap valve) ora noise-reducing flap valve, or both.

For example, described herein are noise-reduced nasal respiratorydevices including a noise reduced airflow resistor comprising anoise-reduction flap valve that is configured to inhibit exhalation morethan inhalation. A noise-reduction flap valve may also be referred to asa “noise reduction flap” or a “noise reduced flap.” The noise-reductionflap valve may be configured so that the edge of the flap does notoscillate during inhalation under a physiological range of inspiratoryflow rates. As mentioned, these devices may include a holdfastconfigured to secure the device in communication with the subject'snasal cavity.

During inhalation through the nasal device, the flow rate of air throughthe nasal device may be between a range of flow rates broadly within therange of between about 1 and about 750 ml/sec. The flow rate duringnormal inhalation may be within this broad range, or within a subset ofthis range. For example, the device may be configured so that the flowrate through the device during inhalation is typically less than about100 ml/sec, less than about 200 ml/sec, less than about 250 ml/sec, lessthan about 500 ml/sec, less than about 750 ml/sec, etc., or betweenabout 1 and 500 ml/sec, 20 and 750 ml/sec, or 20 and 500 ml/sec, or anyother subset of this range. In particular, the noise-reduced devicesdescribed herein may be configured so that the oscillation of the flapvalve (and thus some or all of the noise of the nasal device) is reducedor limited. The device may also be configured so that the noise due toopening and/or closing of the flap valve is limited.

There are many types of flaps that may be used and may be considerednoise-reduction flap valves. One particular variation is abutterfly-type noise-reduction flap. In this variation, the flap is cutor otherwise arranged so that airflow from inhalation causes opposing(and optionally connected) flaps to open, and thereby limit each other'sability to fully open, or to open in parallel with the direction ofairflow through the device. In the butterfly-type flap, the opposingpairs of flaps extend outward to form “wings” that push against eachother, preventing an edge region of the flap face from orienting inparallel with the airflow direction at reasonable physiologicalairflows, which might otherwise lead to oscillation of the flap. Forexample, a noise-reduction flap valve may have a plurality of cutsarranged so that the free edge region of the flap face of the flap valvecannot orient in parallel with the direction of airflow through thevalve during inhalation within a physiologic range of inspiratory flowrates.

In some variations, noise-reduced nasal device include an airflowresistor with a flap having a dampened edge. For example, the dampenedflap edge may be a thickened edge. The damped edge may preventoscillation (vibration) of the free edge of the flap. In somevariations, the edge region is stiffer than other portions of the flap,preventing or inhibiting oscillation. Thus, the edge may be thicker, orit may be made of different material (or both).

In some variations, a noise-reduced nasal device is a nasal devicehaving a flap with a durometer that is greater than 40 (40 Shore A). Forexample, a noise-reduced nasal device may have a flap for the flap valvewith a durometer of about 50. In some variations, the flap valve of thenoise-reduced nasal device has a flap with a durometer of greater thanabout 40 and a thickness that is between about 1 mil and about 5 mil. Insome variations, the flap has a durometer of greater than 40 and athickness that is between about 2 mil and about 4 mil (e.g., the flaphas a durometer of 50 and a thickness of 2 mil, 3 mil or 4 mil). Theflap may be formed of silicone.

As mentioned above, the nasal devices described herein may include oneor more leak pathways configured to remain open during both inhalationand exhalation, even as the airflow resistor opens and closes. Theseleak pathways may also be configured to reduce undesirable noise,including whistling. For example, the leak pathway may be sized orshaped to reduce whistling. In some variations the edges of the leak aresmoothed to prevent whistling. Any of the surfaces through which airflowmay pass through the nasal device may be smoothed to prevent or inhibitwhistling as air moves over or across them. In some variations, thesurfaces of the leak pathway (or other airflow pathways) may be treatedor coated with a material to reduce noise. For example, the leak pathwaymay be coated with a material forming a surface that creates localizedair turbulence.

Any of the nasal respiratory devices described herein may be configuredto have a resistance to exhalation and/or inhalation that is within adesired range. For example, the resistance to exhalation may be betweenabout 10 cm H₂O*sec/L and about 250 cm H₂O*sec/L (e.g., 0.01 and about0.25 cm H₂O/(ml/sec)) when measured at 100 ml/sec. The airflow resistor,leak pathway(s), and also the noise-reduction flap and/or anoise-reduction element may all be configured to achieve this targetresistance to exhalation and/or inhalation. Examples of devices fallingwithin this range of inspiratory and expiratory resistances are providedbelow.

Also described herein are noise-reduced nasal respiratory devicesincluding an airflow resistor comprising a noise-reduction flap valvethat is configured to inhibit exhalation more than inhalation, whereinthe noise-reduction flap valve is further configured so that the freeedge region of the flap face does not orient substantially in parallelwith the direction of airflow through the flap valve during inhalation.The direction of airflow through the flap valve during inhalationgenerally refers to the average direction of airflow through the airflowresistor if the flap were completely removed (a hypothetical “completelyopen” state of the airflow resistor).

As previously mentioned, the noise-reduction nasal devices (includingdevices with noise-reduction flaps) may be configured to have aresistance to exhalation that is between about 0.01 and about 0.25 cmH2O/(ml/sec) and a resistance to inhalation that is between about 0.0001and about 0.02 cm H2O/(ml/sec) when resistance is measured at an airflow of 100 ml/sec.

Also described herein are noise-reduced nasal respiratory devices havingan opening (or passageway) configured to communicate with the nasalcavity, an airflow resistor comprising a flap valve in communicationwith the opening, wherein the airflow resistor is configured to increasethe resistance to air exhaled through the opening more than theresistance to air inhaled through the opening, a noise-reduction elementin communication with the flap valve (wherein the noise-reductionelement is configured to limit oscillation of the flap), and a holdfastconfigured to secure the opening in communication with the subject'snasal cavity. In general, the opening of the nasal device may be anopening or passageway through the nasal device.

The noise-reduction (or noise-reducing) element may be any element thatreduces the oscillation of the flap valve during inhalation but does notsubstantially increase the resistance to inhalation. For example, thenoise-reduction element may include a projecting surface at leastpartially into the opening that prevents an edge region of the flap faceof the flap valve form orienting roughly in parallel with the directionof airflow during inhalation. The projecting surface (which may bereferred to as a “projection”) may be a rib or ribs extending at leastpartially across the opening through the nasal device.

In some variations, the noise-reduction element comprises a cone that isconfigured to prevent the edge region of the flap face of the flap fromopening in parallel or approximately in parallel with the direction ofairflow during inhalation. The height of the cone may be greater than orequal to the height of the flap when the flap is fully opened duringinhalation, and therefore permit control of the entire flap, includingthe free end or tip region. In some cases, the height of the cone may beless than the height of the flap when the flap is fully opened duringinhalation. The tip region is generally the portion (or portions) of theflap that extend farthest from the closed position of the airflowresistor during inhalation. This may also be referred to as the portionof the flap that extends most proximally (into the nose) duringinhalation when the device is worn.

A cone-type noise-reduction element may also include a plurality ofcut-out regions for air passage along the perimeter of the cone. Forexample, the noise-reduction element may be a “castle-topped” cone, inwhich the cone is crenellated. The air passages may extend all the wayto the top surface of the cone, or may be along the sides. In somevariations, the noise-reduction element is a cage configured to preventthe edge region of the flap face from opening approximately in parallelwith the direction of airflow during inhalation. For example, acage-shaped noise-reduction element may be a dome formed of mesh or wirethat does not substantially add to the airflow resistance through thenasal device.

In some variations a noise-reduction element includes a spacerconfigured to prevent the edge region of the flap face of the flap valvefrom opening in parallel with the direction of airflow duringinhalation. For example, the projection into the opening through thenasal device may be a ‘spacer’ that keeps the tip of the flap fromaligning in parallel with the direction of airflow, and thereby fromstalling in the steam of air during inhalation. Multiple spacers may beused.

As mentioned, the noise-reduction element typically does notsubstantially increase the inspiratory resistance, and the resistance toexhalation for the nasal device including a noise-reduction element isgenerally between about 0.01 and about 0.25 cm H₂O/(ml/sec), and theresistance to inhalation is generally between about 0.0001 and about0.02 cm H₂O/(ml/sec) when resistance is measured at 100 ml/sec. In someembodiments the noise-reduction element may minimally or negligiblyincrease the inspiratory resistance.

Also described herein are noise-reduced nasal respiratory devicesincluding an opening (or passageway) configured to communicate with thenasal cavity, an airflow resistor comprising a flap valve incommunication with the opening, wherein the airflow resistor isconfigured to increase the resistance to air exhaled through the openingmore than the resistance to air inhaled through the opening, anoise-reduction element configured to prevent a free edge region of theflap face from orienting itself roughly or substantially parallel withthe direction of airflow through the opening during inhalation, and aholdfast configured to secure the opening in communication with thesubject's nasal cavity. Any of the noise-reduction elements previouslydescribed may be used with these noise-reduction nasal devices.

Also described herein are noise-reduced nasal respiratory devicesincluding an opening (or passageway) through the nasal device configuredto communicate with the nasal cavity, an airflow resistor comprising aflap valve in communication with the opening, wherein the airflowresistor is configured to increase the resistance to air exhaled throughthe opening more than the resistance to air inhaled through the opening,a noise-reduction element projecting into the opening configured toprevent the edge of the flap valve from oscillating, and a holdfastconfigured to secure the device in communication with the subject'snasal cavity. Any of the noise-reduction elements previously describedmay be used with these noise-reduction nasal devices.

Also described herein are methods of decreasing the noise of operationof a nasal device having a flap valve airflow resistor. These methodsmay include the steps of: placing a nasal device at least partially intoor at least partially over a subject's nasal cavity, wherein the deviceincludes a flap valve airflow resistor configured to inhibit exhalationmore than inhalation; and inhibiting the flap valve from oscillatingduring inhalation through the nasal device. In some variations, themethod includes inhibiting the flap valve from oscillating by preventingan edge region of the flap face of the flap valve from orienting itselfin a direction that is roughly or substantially parallel with thedirection of inspiratory airflow through the nasal device. Alternativelythe oscillation of the flap may be inhibited by using a noise-reductionflap valve, as described herein.

The flap valve may be inhibited from oscillating by limiting the motionof the distal tip of the flap valve. The distal tip is also referred toas the portion of the flap that extends most proximally (into the nose)during inhalation when the device is worn.

These methods may also include the step of adhesively securing the nasaldevice at least partly within or at least partly over the subject'snasal cavity.

Also described herein are methods of decreasing the noise of operationof a nasal device that include the steps of: placing a nasal device atleast partially into or at least partially over a subject's nasalcavity, wherein the device includes an opening, a flap valve airflowresistor in communication with the opening, and a noise-reductionelement projecting at least partially into the opening, wherein theflap-valve airflow resistor is configured to inhibit exhalation morethan inhalation; and inhibiting the oscillation of the flap valve duringinhalation through the nasal device by contacting at least a portion ofthe flap valve to the noise-reduction element during inhalation. Forexample, the oscillation may be preventing the edge region of the flapface from orienting in a direction that is roughly or substantiallyparallel with the direction of airflow.

Also described herein are fluttering or vibrating nasal devices.Fluttering or vibrating valves that are configured specifically tooscillate are also described herein. These devices may be referred to as“fluttering” or “vibrating” passive nasal devices. Such nasal devicestypically promote oscillation during inhalation and/or exhalation, andmay promote oscillation of the edge region of the flap face and/or tipof the flap during inhalation and or exhalation. These devices may alsoutilize any of the previously described device features which may beused to prevent oscillation and noise in one direction while promotingoscillation in another direction of airflow. In some variations, thedevices are configured so that the flap valve oscillates at certain(desirable) frequencies. For example, it may be desirous for the flapvalve to oscillate in a range of frequencies that does not produceaudible noise, but does produces the sensation (tactile) of vibration.An oscillating or vibratory flap valve may be used as part of a methodfor treatment of disorders which would benefit from the use of nasalvibration, including the treatment of cystic fibrosis or otherrespiratory disorders.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety, as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference in its entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are bottom and top perspective views, respectively, ofone variation of a nasal device.

FIGS. 2A and 2B show one variation of a layered nasal device in a topview and an exploded perspective view, respectively.

FIGS. 3A to 3C illustrate operation of flap valves having four, six andeight flaps, respectively, during simulated inspiratory flow.

FIGS. 4A to 4C show various dome-shaped noise-reduction elements.

FIGS. 5A to 5D show noise-reduction elements configured as projections.

FIGS. 6A to 6C show conical noise-reduction elements.

FIGS. 7A to 7C show perspective, top and side cross-sectional views,respectively of one variation of a noise-reduction element configured asa cone.

FIGS. 8A to 8F show perspective views of variations of cone-typenoise-reduction elements.

FIG. 9A shows a conical noise-reduction element having a low height, andFIG. 9B shows a portion of a nasal device including a conicalnoise-reduction element having a low height.

FIG. 10 is another variation of a noise-reduction element configured asa cone.

FIG. 11 illustrates variations of flaps which may be used as flapvalves.

FIG. 12A is a butterfly-type noise-reduction flap. FIG. 12B illustratesthe operation of the noise-reduction flap of FIG. 12A during a simulatedinspiratory flow.

FIG. 13A is another variation of a noise-reduction flap. FIG. 13Billustrates the operation of the noise-reduction flap of FIG. 13A duringa simulated inspiratory flow.

FIG. 14A is another variation of a noise-reduction flap. FIG. 14Billustrates the operation of the noise-reduction flap of FIG. 14A duringa simulated inspiratory flow.

FIG. 15A is another variation of a noise-reduction flap. FIG. 15Billustrates the operation of the noise-reduction flap of FIG. 15A duringa simulated inspiratory flow.

FIG. 16A shows a noise-reduction element. FIG. 16B shows a flap valvethat may be used with the nose-reduction element shown in FIG. 16A, andFIG. 16C shows a nasal device including the noise-reduction element ofFIG. 16A and the flap of FIG. 16B.

FIG. 17 is a cross-section though a noise-reduced nasal device havingboth a noise-reduction cone and a noise-reduction flap.

FIG. 18 is an exploded view of a noise-reduced nasal device including anoise-reduction element.

FIGS. 19A to 19C are three variations of noise-reduction elements.

FIG. 20 is an exploded view of a noise-reduced nasal device including anoise-reduction flap.

DETAILED DESCRIPTION OF THE INVENTION

Described herein are noise-reduced nasal devices. Noise-reduced nasaldevices typically include a noise-reduced feature such as anoise-reduction flap for a flap valve, a noise-reduction element, orboth. The noise-reducing features described are configured as part ofthe nasal device so that the resistance to exhalation and inspiration ofthe nasal devices is typically between about 0.01 and about 0.25 cmH₂O/(ml/sec) for exhalation and between about 0.0001 and about 0.02 cmH₂O/(ml/sec) for inspiration when resistance is measured at 100 ml/sec.Inspiratory resistance or resistance to inhalation, refers to theresistance to airflow moving though the device in the direction ofinhalation when the device is oriented as it would be when worn by auser. Likewise, expiratory resistance or resistance to exhalation refersto the resistance to airflow through the device in the direction ofexhalation when the device is oriented as it would be when worn by auser.

As used herein, the term noise-reduced nasal device or noise-reductionnasal device refers to any nasal device that includes one or morenoise-reduction features, such as a noise-reduction flap valve asdescribed and exemplified herein, or a noise-reduction element asdescribed herein. Noise reduction typically refers to the reduction orelimination of noise such as buzzing, whistling, hissing or othervibratory or airflow noise which may be heard or sensed by a subjectwearing a nasal device. These noises typically arise from theundesirable and unnecessary oscillation of the flap valve forming theairflow resistor in the nasal device.

As used herein, the singular forms “a,” “an,” and “the” include pluralreference unless the context clearly dictates otherwise.

The noise-reduction features described herein may be used with anyappropriate nasal devices, particularly those having a flap valve.Before describing the noise-reduction features, examples of nasaldevices that may be used with these noise-reduction features are firstdescribed.

Nasal Devices

Any appropriate nasal device may be configured as a noise-reductionnasal device, including the adhesive nasal devices described in moredetail in FIGS. 1A to 2B, below. The noise-reduction nasal devicesdescribed herein typically include a passageway configured tocommunicate with a subject's nasal passage (or cavity), a flap-valveairflow resistor in communication with the passageway, and anoise-reduction feature.

The nasal devices described herein may be secured in communication witha subject's nose, and specifically with one or both of the subject'snasal cavities. A typical nasal device includes an airflow resistor thatis configured to resist airflow in a first direction more than airflowin a second direction, and may also include a holdfast configured tosecure the airflow resistor at least partially over, in, and/or acrossthe subject's nose or nostril. The holdfast may include a biocompatibleadhesive and a flexible region configured to conform to at least aportion of a subject's nose. The nasal devices described herein arepredominantly adhesive nasal devices, however the noise-reducingfeatures described may be used with nasal devices that are not adhesivenasal devices, including nasal devices having compressible or expandableholdfasts. Other embodiments include nasal devices in which the holdfastis mask that fits over the nose, the mouth or both the nose and mouth.

Nasal devices may be worn by a subject to modify the airflow thoroughone or (more typically) both nostrils. Nasal devices may be secured overboth of a subject's nostrils so that airflow through the nostrils passesprimarily or exclusively through the nasal device(s). Adhesive nasaldevices are removably secured over, partly over, and/or at least partlywithin the subject's nostrils by an adhesive. The nasal devicesdescribed herein may be completely flexible, or partially rigid, orcompletely rigid. For example, the devices described herein may includean adhesive holdfast region that is at least partially flexible, and anairflow resistor. The airflow resistor may be flexible, or rigid. Insome variations, the devices described herein also include one or morealignment guides for helping a subject to orient the device whensecuring it over the subject's nose. The alignment guide may alsoinclude or be configured as a noise-reduction element, as described ingreater detail below. The adhesive nasal devices described herein may becomposed of layers. Nasal devices composed of layers, which may also bereferred to as layered nasal devices, may be completely or partiallyflexible, as previously mentioned. For example, a layered nasal devicemay include an airflow resistor configured to resist airflow in a firstdirection more than airflow in a second direction and an adhesiveholdfast layer. In some variations, the airflow resistor may be a flapvalve layer adjacent to a flap valve limiting layer, and may include anadhesive holdfast layer comprising an opening across which the airflowresistor is operably secured. The airflow resistor may be disposedsubstantially in the plane of the adhesive holdfast layer. The adhesiveholdfast layer may be made of a flexible substrate that includes anadditional layer of biocompatible adhesive.

The nasal devices described herein may be considered as passive nasaldevices, because the flap valve may operate to passively regulate asubject's respiration. For example, a nasal device may create positiveend expiratory pressure (“PEEP”) or expiratory positive airway pressure(“EPAP”) during respiration in a subject wearing the device. In contrastto active nasal devices, such as CPAP machines that apply positivepressure to the subject, the passive devices described herein do notrequire the addition of pressurized respiratory gas.

The noise-reduced nasal devices and methods described herein may beuseful to treat a variety of medical conditions, and may also be usefulfor non-therapeutic purposes. For example, a nasal respiratory devicemay be used to treat sleep disordered breathing or snoring. The systems,devices and methods described herein are not limited to the particularnasal device embodiments described. Variations of the embodimentsdescribed may be made and still fall within the scope of the disclosure.

As used herein, a nasal device may be configured to fit across, partlyacross, at least partly within, in, over and/or around a single nostril(e.g., a “single-nostril nasal device”), or across, in, over, and/oraround both nostrils (“whole-nose nasal device”). Any of the featuresdescribed for single-nostril nasal devices may be used with whole-nosenasal devices, and vice-versa. In some variations, a nasal device isformed from two single-nostril nasal devices that are connected to forma unitary adhesive nasal device that can be applied to the subject'snose. Single-nostril nasal devices may be connected by a bridge (orbridge region, which may also be referred to as a connector). The bridgemay be movable (e.g., flexible), so that the adhesive nasal device maybe adjusted to fit a variety of physiognomies. The bridge may beintegral to the nasal devices. In some variations, single-nostril nasaldevices are used that are not connected by a bridge, but each include anadhesive region, so that (when worn by a user) the adhesive holdfastregions may overlap on the subject's nose.

One variation of a nasal device that may include a noise-reductionfeature (e.g., a noise-reduction flap or noise-reduction element) is alayered nasal device, formed of two or more layers. For example, alayered nasal device may include an adhesive holdfast layer and anairflow resistor layer. These layers may themselves be composed ofseparate layers, and these layers may be separated by other layers, orthey may be adjacent. For example, the adhesive holdfast layer may beformed of layers (optionally: a substrate layer, a protective coveringlayer, an adhesive layer, etc), and thus may be referred to as a layeredadhesive holdfast. Similarly, the airflow resistor may be formed ofmultiple layers (optionally: a flap valve layer, a valve limiter layer,etc.), and thus may be referred to as a layered airflow resistor. Insome variations, the layered adhesive holdfast and the layered airflowresistor share one or more layers. For example, the flap valves layerand the adhesive substrate layer may be the same layer, in which theleaflets of the flap valve layer are cut from the substrate layermaterial. As used herein, a “layer” may be a structure having agenerally planar geometry (e.g., flat), although it may have athickness, which may be uniform or non-uniform in section. As mentionedbriefly above, the support backing may be formed of one of the layers ofa layered nasal device, such as the adhesive substrate layer.

In some variations, a nasal device has a body region including apassageway configured to be placed in communication with a subject'snasal passage. The body region may be a stiff or flexible body region,and may secure an airflow resistor therein. In some variations, the bodyregion is at least partially surrounded by a holdfast (i.e., a planaradhesive holdfast). The body region may be modular, meaning that it isformed of two or more component sections that are joined together.Examples of such nasal devices can be found in U.S. Pat. No. 7,506,649,filed on Jun. 7, 2007, and previously incorporated by reference in itsentirety. As described therein, the body region may be configured sothat it does not irritate a subject wearing the nasal device. Forexample, the body region may be slightly undersized compared to the sizeof the average user's nostrils. Thus the body region may fit into thesubject's nose, and the seal with the subject's nose is formed by theadhesive holdfast region, rather than the body region. In somevariations the body region does not substantially contact the innerwalls of the subject's nose. Furthermore, the body region may extendonly slightly into the subject's nose.

In some variations, the adhesive nasal device includes a support frame.The support frame may provide structural support to all or a portion ofthe nasal device, such as the flexible adhesive portion. For example,the support frame may support the adhesive holdfast portion of thedevice and be completely or partially removable after the device hasbeen applied to the subject. In some variations, the support frameremains on the nasal device after application. In some variations, thesupport frame is a support frame layer.

An adhesive nasal device may also include a tab or handle configured tobe grasped by a subject applying the device. In some variations, thistab or handle is formed of a region of the layered adhesive holdfast.

The various components of the device may be made of any appropriatematerials, as described in greater detail below. For example, somedevice components (e.g., an alignment guide, a body region,noise-reduction element) may be made of medical grade plastic, such asAcrylonitrile Butadiene Styrene (ABS), polypropylene, polyethylene,polycarbonate, polyurethane or polyetheretherketone. The airflowresistor may be a flap valve and the flap may be made of silicone orthermoplastic urethane. The adhesive holdfast may include an adhesivesubstrate made of silicone, polyurethane or polyethylene. Examples ofbiocompatible adhesive on the adhesive holdfast may includehydrocolloids or acrylics. These lists of materials are not exclusive,and other (or alternative) materials may be used.

In some versions, the nasal device further comprises an active agent. Insome versions, this active agent is a drug (e.g., a medicament). In someversions, this active agent comprises an odorant, such as a fragrance.In some versions, the active agent comprises menthol, eucalyptus oil,and/or phenol. In other versions, the nasal device may be used withother pulmonary or medical devices that can administer medication orother medical treatment, including, but not limited to, inhalers andnebulizers.

A nasal device may include a filter. This filter may be a movablefilter, such as a filter that filters air flowing through the passagewayin one direction more than another direction (e.g., the device mayfilter during inhalation but not exhalation).

As mentioned, the adhesive nasal devices described herein typicallyinclude a holdfast region (or layer) and at least one airflow resistor.As will be apparent from the figures, many of these nasal devices may beremovable and insertable by a user without special tools. In somevariations, a subject may use an applicator to apply the device (e.g.,to help align it). FIGS. 1A through 2B illustrate different exemplarynasal devices.

FIGS. 1A and 1B show perspective views of one exemplary variation of anadhesive nasal device that may be configured as a noise-reduced nasaldevice and may include a noise-reducing feature (not apparent in thesefigures). FIG. 1A shows a front perspective view of an adhesive nasaldevice, looking at the “outer” side of the device, which is the sidefacing away from the subject's nose when the device is worn. The deviceshown in FIG. 1A includes two single-nostril rim bodies 101 and a singleadhesive holdfast 104. A nasal device may be configured to communicatewith a single nostril (a single-nostril nasal device), or it may beconfigured to communicate with both of a subject's nostrils (adouble-nostril nasal device as shown here).

The holdfast 104 (which adhesively secures the device to the subject) isshown as a layered structure including a backing or adhesive substrate105. This backing may act as a substrate for an adhesive material, or itmay itself be adhesive. The holdfast 104 may have different regions,including two peri-nasal regions surrounding the rim bodies 101. Eachrim body has at least one passageway 108 for airflow therethrough. Theadhesive holdfast also includes two tabs or grip regions 110 that maymake the device easier to grasp, apply, and remove. A bridge region 112is also shown. In this example, the bridge region is part of theadhesive holdfast (e.g., is formed by the same substrate of the adhesiveholdfast) and connects the peri-nasal regions. Although the tab andbridge regions are shown as being formed as part of (integral with) theholdfast material, these regions may also be formed separately, and maybe made of different materials.

The rim body regions 101 shown in the exemplary device of FIG. 1Ainclude outer rim body regions which each encompass a passageway 108.These first (e.g., outer) rim body regions may mate with second (e.g.,inner) rim body regions to form the rim body region(s) of the devicethat each include a passageway 108. This passageway is interrupted bycrossing support members 114 (e.g., cross-beams or cross-struts) thatmay partly support or restrict movement of the airflow restrictor. Inaddition, each rim body region 101 includes two leak pathways 116,through which air may pass even when the passageway through the deviceis otherwise blocked by the airflow resistors. The leak pathways 116 areshown here as small openings at the narrow ends of the oval-shaped outerrim body region. The rim body region may also be referred to as ‘rim’ or‘scaffold’ regions of the device.

FIG. 1B shows a back perspective view of the opposite side of theadhesive nasal device shown in FIG. 1A, the “inner side” of the device.The inner side of the device faces the subject, and a portion of thisside of the device may contact the subject. This side of the device, andparticularly the adhesive holdfast of the device, includes an adhesive(which may be covered by a protective cover 107) forming part of theholdfast 104. In some variations, the entire skin-facing side of theholdfast 104 includes an adhesive on the surface, although in somevariations, only a portion of this region includes adhesive. Theadhesive may be a distinct layer of the holdfast (e.g., it may belayered on top of an adhesive substrate), or it may be an integral partof the holdfast (e.g., the adhesive substrate may be made of an adhesivematerial). In some variations an adhesive may be separately added to thedevice (e.g., the holdfast region) before use. The adhesive material maybe covered by a removable protective cover or liner 107, to prevent theadhesive from sticking to surfaces until after the liner is removed. InFIG. 1B, the protective cover 107 covers the entire skin-facing surfaceof the holdfast. The device may be applied by first removing the liner.For example, the liner may be peeled off, to expose the adhesive. Insome variations, the liner protecting the adhesive may be partiallyremoved. For example, the tab region 121 of the device may include aseparate (or additional) liner that remains over the tab region whenother liner regions are removed. This may allow the device to be held bythe tab region without having it adhere to the skin. After removing thecover, or a part of the cover, the device may be positioned and adheredto the subject's skin around the nasal cavity, so that the passagewaysthrough the rim body are aligned with the openings of the subject'snasal cavities. In some variations, an additional adhesive cover region(e.g., the protective cover region over the tabs 121) can then beremoved to secure the device to the rest of the subject's nose. Theadhesive cover may include a fold (or crimp, crease, lip, or the like)that helps to remove the protective cover from the adhesive.

The second, or inner, rim body region 103 shown in the exemplary deviceof FIG. 1B is shaped with an inwardly-tapering edge, so that it may fitat least slightly within the opening of the subject's nostril when asubject wears the device. The inner rim body includes one or morepassageways 108 that correspond with the passageways 108 shown in FIG.1A. Similarly, the leak pathways pass completely through the rim body(both inner and outer bodies). The tapering external walls of the innerrim body region(s) shown in FIG. 1B are shown as smooth, and may alsoinclude an additional material (e.g., an auxiliary holdfast material)for securing them in the subject's nostrils, or for cushioning them toprevent injury or discomfort. These surfaces may also be more or lessangled, in order to facilitate comfort when the adhesive nasal device isworn in the subject's nose. A cross bar (hinge region 115) may also beprovided as part of the inner rim body. The inner rim body 103 mayextend some distance above the peri-nasal annular region of theholdfast, as shown in FIG. 1B. This distance may be sufficient toprevent any portion of the airflow resistor (e.g., a flap portion of aflap valve) from extending out of the device and into the nasal cavitywhere it might contact body tissues. In some variations, the inner bodyregion includes one or more noise-reduction elements, such as aprojection at least partially into the passageway that prevents an edgeregion of the flap face of the flap valve from orienting in parallelwith the direction of airflow during inhalation.

All of the nasal devices described herein also include an airflowresistor, which is located in one or more passageways formed through thedevice. In FIGS. 1A and 1B, the airflow resistor is a flap valve, andincludes cross bars that support the flap valve (and can prevent it fromopening during exhalation). In general, the airflow resistor opens inone direction (during inhalation) and is closed during exhalation. Theflap may be made of silicone. In the device shown in FIGS. 1A and 1B,the flap can be secured between the inner and outer rim bodies. The flapvalve may also be configured so that the flap is a noise-reduction flap,as described in greater detail below.

FIG. 2A is a top view of another example of a nasal device. The nasaldevice shown in FIGS. 2A-2B is a layered nasal device that includes aholdfast layer 201 and an airflow resistor 203. The reverse side of thedevice shown in FIG. 2A includes an adhesive material (not shown) thatmay be covered by a protective covering. The protective covering (whichmay also be referred to as a protective liner) can be removed to exposethe adhesive before application of the device. Thus, the holdfast layerof the device secures it to the subject. This holdfast layer may itselfbe layered, and may include an adhesive substrate (e.g., a backinglayer). For example, the adhesive substrate may be a foam backing. Thisbacking may act as a substrate for an adhesive material. In somevariations, the adhesive substrate is itself adhesive. The holdfastlayer 201 may have different regions, including a peri-nasal regionssurrounding a passageway (though which air may flow), and a tab 205 orgrip region forming a tab that may make the device easier to grasp,apply and remove. Other regions may include regions of more aggressiveand less aggressive adhesive (e.g., more or less adhesive material), orregions of hydrogel material (including adhesive hydrogels) to helpprevent irritation from repeated or extended use. Although the tab isshown as part of (integral with) the holdfast material, this region mayalso be formed separately, and may be made of different materials.

FIG. 2B shows an exploded view of the device of FIG. 2A. This explodedperspective view illustrates the layers of the device, including theadhesive holdfast 201 (which may itself be layered), two layers formingthe airflow resistor, including the flap valve 207 and flap valvelimiter 209, and an adhesive ring 211 that may help attach the flapvalve and flap valve limiter to the adhesive holdfast.

An adhesive holdfast for a nasal device may comprise any appropriatematerial. For example, the adhesive substrate may be a biocompatiblematerial such as silicone, polyethylene, or polyethylene foam. Otherappropriate biocompatible materials may include some of the materialspreviously described, such as biocompatible polymers and/or elastomers.Suitable biocompatible polymers may include materials such as: ahomopolymer and copolymers of vinyl acetate (such as ethylene vinylacetate copolymer and polyvinylchloride copolymers), a homopolymer andcopolymers of acrylates (such as polypropylene, polymethylmethacrylate,polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate,ethylene dimethacrylate and hydroxymethyl methacrylate, and the like),polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene,polyamides, fluoropolymers (such as polytetrafluoroethylene andpolyvinyl fluoride), a homopolymer and copolymers of styreneacrylonitrile, cellulose acetate, a homopolymer and copolymers ofacrylonitrile butadiene styrene, polymethylpentene, polysulfonespolyimides, polyisobutylene, polymethylstyrene and other similarcompounds known to those skilled in the art. Structurally, the substratemay be a film, foil, woven, non-woven, foam, or tissue material (e.g.,poluelofin non-woven materials, polyurethane woven materials,polyethylene foams, polyurethane foams, polyurethane film, etc.).

In variations in which an adhesive is applied to the substrate, theadhesive may comprise a medical grade adhesive such as a hydrocolloid oran acrylic. Medical grade adhesives may include foamed adhesives,acrylic co-polymer adhesives, porous acrylics, synthetic rubber-basedadhesives, silicone adhesive formulations (e.g., silicone gel adhesive),and absorbent hydrocolloids and hydrogels.

Noise-Reduced Nasal Devices

As mentioned above, nasal devices including those illustrated in FIGS.1A-2B may produce undesirable noises when worn, particularly duringinhalation, when the rate of airflow through the device is greatest. Ananalysis of these devices has identified oscillation of the flap portionof the valve during inspiratory airflow as one possible source of noise.In particular, the edge portion of a flap may vibrate or oscillateduring the inspiratory phase of respiration causing an audible buzzingnoise, particularly at relatively high flow rates during inhalation.

Any of the noise-reduced nasal respiratory devices described herein maybe configured so that the flap valve does not produce nose fromoscillation during operation of the device in a range of normalinhalation and/or exhalation flow rates. Typical flow rates foroperation during inhalation may be between about 20 and about 750ml/sec, or between about 20 and about 500 ml/sec, or between about 10and about 800 ml/sec, etc.). The flow rate typically refers to the flowrate through the device during inhalation (or in some variations,exhalation).

For example, FIGS. 3A-3C show different flap valve variations during asimulated inhalational air flow. These figures capture the oscillationof the flaps of the flap valves which may produce an audible buzzingsound. For example, FIG. 3A illustrates a flap valve comprising fourvalve leaflets (flaps), formed as a four-piece pie-shaped valve having acentral opening or leak pathway. During inhalation, the four flaps bendupwards, opening the valve. As shown in the photograph, the upper (tip)regions of the valves in this figure are blurred, because they areoscillating a relatively high frequency in the simulated inspiratoryairflow. The flap on the right side of the figure shows a tracingindicating the angle formed by the valve as it oscillates. In thisexample, the valve was measured to oscillate through an approximately 35degree angle of arc. The rate at which the valve oscillates may dependon the airflow, the material properties of the valve (including thestiffness), and the shape of the valve. The rate of oscillation may alsodetermine the frequency or pitch of the resulting noise. In somedevices, buzzing was not in the audible range until one or more flapswas constrained; preventing or limiting flow through one flapeffectively increased the rate of flow through the other flaps,increasing the rate of oscillation.

FIGS. 3B and 3C are similar examples showing six-leaflet (FIG. 3B) andeight-leaflet (FIG. 3C) valves during a simulated inspiratory airflow.In all of these examples, the unconstrained ends or edge of the flapsare oscillating within the inspiratory airflow. “Buzzing” may resultwhen a flap is allowed to open vertically aligning with the airflow andvibrate in the passing airstream.

In theory, the flap oscillates and produces noise when the force of airpressure on opposite sides of the flap becomes dynamically unstable,resulting in the back and forth (oscillatory) motion of the flap as theunstable forces acting on either side of the flap push on the flap. Thisphenomenon may be similar to the motion that the sail of a sailboatundergoes when the sail “luffs”. Based on an analysis of the flaps offlap valve nasal devices during simulated inspiratory airflow, itappears that oscillation occurs when the flap valve luffs when an edgeface region of the flap becomes aligned in parallel with the airflowthrough the device. When this occurs, the air pressure on either side ofthe flap pushes the flap back and forth, oscillating it. Thisoscillation may produce a buzzing noise.

Constraining the oscillation of the flap may reduce or eliminate noise.For example, a flap may be constrained by limiting the ability of theedge (particularly the distal tip region) to oscillate. Alternatively,or in addition, a flap, and particularly the edge region of the flap,may be dampened to reduce or eliminate the oscillation. Finally, theflap may be prevented from oscillating by preventing an edge region ofthe flap face of the flap from aligning with the inspiratory airstream.

Noise-reduction features therefore include elements for constraining theoscillation of the edge region of a flap. Buzzing, apparently a resultof the oscillations, may be reduced or prevented by including anoise-reduction feature that prevents the flaps forming the flap valvefrom opening so that an edge region of the flap face of the flap isessentially parallel with the direction of airflow through the device.Any appropriate structure for constraining the oscillation may be usedas a noise-reduction element, including cages, spacers, cones, ortethers. Examples of these noise-reduction elements are given below.

Noise-reduction elements may be attached to the nasal device on theproximal side of the device (e.g., the side facing the subject, in thedirection of inspiratory airflow. For example, a noise-reduction elementmay be a cone or cage (e.g., dome) that is placed over or partiallyacross the passageway of the device so that it may control the edge ortip of the flap. In some variations the nose-reducing element may alsoact as an alignment guide, and may protect the valve or flap valve frominterference. The noise-reduction element may also prevent the flapsfrom contacting a subject's nose, which would interfere with theiroperation and could irritate the subject's nose or causing a ticklingsensation.

In general, noise-reduction elements limit the oscillation of the flap.FIGS. 4A to 4C illustrate noise-reduction elements configured as domesor cages that extend over the proximal side of the passageway and limitthe motion of the flap valves to prevent them from buzzing. For example,FIG. 4A is a wire dome 401 that surrounds the flaps 405 of the flapvalves. The dome has large openings, but the wires forming the domeprevent the flaps of the valve from opening completely. In particular,they prevent an edge region of the flap face from opening in parallelwith the direction of airflow through the valve. The arrow 408 indicatesthe net direction of airflow during inhalation. In this example, thewalls forming the dome curve inward slightly, preventing the flap(s)from opening fully during inhalation. In some variations, the dome orcage has a height that is less than the full extension of the flaps ifthey were to open in parallel with the direction of airflow. An exampleof this is shown in FIG. 4B.

In FIG. 4B the noise-reduction element is configured as a dome formed ofa plastic mesh. In this example, the ‘wires’ forming the dome arethicker than those shown in FIG. 4A, and the openings in thenoise-reduction element are smaller than those in the noise-reductionelement of FIG. 4A. The resistance through the dome (during bothinspiration and exhalation), may therefore be slightly higher than theresistance without the dome, or compared to the device shown in FIG. 4A.The example of a noise-reduction element shown in FIG. 4C may have aneven greater effect on the resistance to airflow through the nasaldevice. In this example the dome is formed of a plastic (e.g., shaped ormolded plastic) cut to provide openings (circular openings in thisexample). These openings may be larger and/or more numerous, in order toadjust the effect on the resistance to inspiration. In this way theresistance to inspiration (and exhalation) can be adjusted so that it iswithin a desired range.

FIGS. 5A-5D show variations of nasal devices including noise-reductionelements configured as spacers that are formed as part of a body regionas described above for FIGS. 1A and 1B. For example, in FIG. 5A theinner body region includes a cross-beam with two projections or spacers503, 503′ extending into the passageway to contact the distal tips ofthe flaps during inhalation, and prevent them from oscillating. In thisexample, the edge region of the flap face is prevented from aligningwith the direction of airflow (perpendicular to the opening in FIG. 5A).As discussed above, this may prevent the flaps from oscillating. In FIG.5A these projections 503, 503′ extend downwards toward the flap valve.Any projection that prevents the edge region of the flap valve fromoscillating (e.g., that prevents the edge region of the flap face fromaligning parallel to the direction of airflow) may work. Thenoise-reduced nasal device shown in FIG. 5B is similar to the deviceshown in FIG. 5A, except that the noise-reduction elements (projections503, 503′) are longer, and therefore extend further in thepassageway(s). FIGS. 5C and 5D illustrate another variation of a nasaldevice including noise-reduction elements that are configured asprojections.

For example, in FIG. 5C, the noise-reduction element is a pair of spacedprojections 505,505′ and 507, 507′ arranged so that each of the pair offlaps valves (not visible in the figure) will contact both of them whenopening during inspiration. The spacing between the two projections mayalso help control the air pressure on one side of the flap, since thespace formed between the two projections on each side will allow a gappreventing pressure to build up between a face of the flap and thecross-beam or projection spanning the passageway. This may help furtherprevent oscillation of the flap by maintaining the pressure differentialwith respect to the opposite face of the flap. The noise-reduced nasaldevice shown in FIG. 5D is similar to that shown in FIG. 5C, except thatthe projections are smaller (e.g., don't extend as far across thepassageway(s) formed through the device). The size and/or number of theprojections used to reduce or eliminate noise may depend on the materialproperties (such as stiffness) of the flap valve and the velocity of theexpected airflow. For example, more projections that may be used withlarger flap valves.

Other configurations of noise-reduction projections may include ribs orarcs that extend at least partially across the opening or passageway.These projections do not need to be part of a cone (e.g., an alignmentcone or other structure) as illustrated in FIGS. 5A-5C, but may projectfrom the side of the device near the flap valve (or from the holdfastregion). In some variations a noise-reduction element is a cone (whichmay also be an alignment guide) that controls the edge regions of a flapto prevent it from oscillating and thereby reduce or eliminate noisesuch as buzzing.

For example, FIGS. 6A-6C illustrate three variations of noise-reductionelements configured as cones. Other examples of conical noise-reductionelements are shown in FIGS. 7A-10.

In FIG. 6A the cone extends up from the valve so that the top of thecone is as high as, or slightly higher than, the tip of the flap valves.In this example, the inner walls of the cone are slightly angled inward,so that the distal edge region of the flap face (the edge region of theflap face facing away from the subject when the device is worn) cannotmove out of the path of the inspiratory airflow. Put another way, thedistal edge regions of the flap face cannot become parallel with the netdirection of air flow through the passageway of the device. The coneincludes openings (cutout regions) 605 near each flap that may alsoprevent pressure from building up behind the flap as it nears the wall,potentially introducing instability. The openings may also (oralternatively) provide another path for airflow, helping to compensatefor the size of the opening at the top of the cone, and keep inspiratoryresistance low. FIGS. 6B and 6C illustrate different variations of conesthat may also be used.

For example, FIG. 6B shows a simple formed cone that does not includeany cutout regions. FIG. 6C shows a similar cone having a castle-topped(or crenellated) form in which cutouts have been made along the sides.In variations including cutouts or crenellations, the number of sidecutouts is generally equal to at least the number of flaps. For example,in FIG. 6C there are eight flaps (cut to form a flap valve having eight“pie slices”) and eight cuts forming eight crenellations. As mentioned,the cut out regions 607 may unexpectedly improve the noise-reducingcapability compared to the simple formed cone of FIG. 6B. When tested athigh flow rates (simulating a high inspiratory flow rate), thecastle-topped variation shown in FIG. 6C produced less noise compared tothe simple cone shown in FIG. 6C.

FIGS. 7A-7C illustrate another variation of a noise-reduction elementconfigured as a simple formed cone, showing exemplary dimensions. Forexample, FIG. 7A shows a side perspective view of a conicalnoise-reduction element similar to that shown in FIG. 6B. FIG. 7B showsa top view of the same conical noise-reduction element. FIG. 7C is aside view indicating relative thicknesses and angles for the samenoise-reduction cone. This basic noise-reduction cone may be cut tocreate the castle-topped variation or any other conical noise-reductionelement. Examples of additional variations of conical noise-reductionelements are shown in FIGS. 8A-8F.

FIGS. 8A through 8C show cones designed to prevent flap vibration havingone or more projection into the passageway region. For example, FIG. 8Ais configured to be used with a flap valve having six flaps (cut from acircular flap disk). There are three corresponding projections 803 thatare configured to prevent an edge region of the flap face from orientingparallel to the direction of fluid flow. FIG. 8B is a similar conicalnoise-reduction element having four projections 805 rather than three,and may be used with an eight-flap variation. FIG. 8C is anothervariation having a ring-shaped projection to prevent flap buzz. The conehaving a ring-shaped projection has the advantage that it can be usedany flap valves regardless of the number of flaps, and further, theprojections do not need to be aligned with the flaps, as may need to bedone with the conical noise-reduction elements shown in FIGS. 8A and 8B.In the examples shown in FIGS. 8A-8C the walls of the cones may berelatively flat or parallel to the direction of airflow. Thus, althoughthese are referred to as “cones” or conical noise-reduction elements,the walls don't angle substantially into the passageway, although theprojections may. These variations may also include cutouts in the sidesof the device, which may lower the inspiratory resistance, and also helpprevent oscillation of the flap.

FIGS. 8D to 8F illustrate conical noise-reduction elements havinginternal walls that angle inward to prevent the oscillation of the flap.FIG. 8D is similar to the example of FIG. 6A, having angled sides andcutouts. FIGS. 8E and 8F are different variations of castle-topped orcrenellated cones having cutout regions that extend to the upper edge ofthe device. The method of making these two similar cones may be quitedifferent. For example, the cone forming the noise-reduction element inFIG., 8E may be formed by molding a simple formed cone similar to theformed cone shown in FIG. 7A. The noise-reduction element of FIG. 8F canbe formed by cutting a disk of material and bending or folding it up sothat it forms the cone structure shown.

A conical noise-reduction cone should be sufficiently tall so that theentire flap, including the tip region is controlled. Preventing the edgeregion of the flap face, including the tip region of the flap, fromaligning with the direction of inspiratory airflow should prevent theflap from oscillating. FIGS. 9A and 9B illustrate one variation of acone that only minimally inhibits noise due to buzzing or oscillation ofthe flaps. For example, FIG. 9A shows a short cone. When connected to anasal device, this short cone may not project proximally sufficientlyfar to prevent an edge region of the flap face from oscillating, sincethe tips (the proximal ends of the movable flaps) may extend beyond thecone, as shown in the example of FIG. 9B. Thus, the height of the coneor other noise-reduction element should extend far enough to limit orprevent oscillation of the tip regions of the flap. FIG. 10 illustratesa taller variation of the cone that may be sufficiently tall compared tothe element shown in FIG. 9A.

FIG. 16A shows another example of a noise-reducing cone having anoise-reducing element 1601 that projects into the passageway andprevents the flap valve 1603, an example of which is provided in FIG.16B, from orienting in parallel with the direction of airflow. Theprojection 1601 contacts the distal tip region of the flap valve 1603,constraining it from orienting in parallel with the direction ofairflow. FIG. 16C illustrates a nasal device, shown as an adhesive nasaldevice, that may be applied to the subject's nose.

Noise-Reduction Flap Valves

Noise-reduction flap valves typically include one or more flaps whoseshapes and/or composition limit or prevent oscillation of the flap. Forexample a noise-reduction flap may constrain or limit an edge region ofthe flap face from aligning in parallel with the direction of airflow.Noise-reduction flap designs may provide flaps whose edges are eithertethered, and therefore prevented from extending in the direction ofairflow, or include one or more cuts which cause the flap to assume athree-dimensional configuration when the airflow through the valve iswithin the normal inspiratory range wherein the edge region of the flapfaces are not able to align with the direction of airflow or otherwiseoscillate.

FIG. 11 illustrates examples of a number of flap valves, some of whichare noise-reduction flap valves. Although these flaps are formed from acircular layer, any appropriate flap design may be used. For example, aflap (including a noise-reduced flap) may be oval or may be pinned orotherwise attached to the nasal device, rather than being partially cutout of a substrate. FIGS. 12A-15B show specific examples ofnoise-reduced flaps and illustrate principles that may help design them.

FIG. 12A is a butterfly noise-reduction flap valve. FIG. 12B shows thebutterfly noise-reduction flap valve (which may also be referred to as adouble-butterfly flap valve) in an open configuration, when inspiratoryairflow is flowing through the flap valve. As seen in FIG. 12B, theflaps open in two opposing directions; the outer flaps formed by the twoouter cuts 1201, bend upwards, but are prevented from folding upwardsand aligning with the direction of airflow in the valve by the flapsformed by the inner H-shaped cut 1203. These flaps also open upward, butpush against the other flaps, preventing them from aligning with thedirection of airflow, as shown. The additional cuts also shorten theeffective bendable length of the flap, making the flap stiffer, andrequiring greater inspiratory force in order to fully align a face ofthe flap with the direction of airflow. Thus, this butterfly flap is onevariation of a noise-reduction flap valve.

FIG. 13A is another variation of a noise-reduction flap valve alsohaving outer cuts and inner cuts which form flaps that may oppose eachother and form a three-dimensional shape in the inspiratory airflowpathway. FIG. 13B shows this flap valve in the open position in anexemplary inspiratory airflow. In this example, as in the butterfly-typeflap valve, the open flaps are constrained (at normal inspiratory flowrates) from opening so that one or more edge face regions are aligned inparallel with the direction of inspiratory airflow and therefore theyare constrained from oscillating.

Two other variations of noise-reduction flap valves are illustrated inFIGS. 14A-15B. For example, in FIG. 14A, the clover-leaf pattern ofinternal flaps cut into each of the four larger flaps results inopposing pairs of flaps (e.g., each inner flap is opposed by an outerflap) that open in opposite directions, similar to the butterfly flapvalve of FIGS. 12A-12B.

In all of these flap valve designs shown in FIGS. 12A-15B the opening ofthe outer flaps is opposed by the opening of an inner flap that istypically cut into the outer flap. As a result of the opposing flapopenings, neither inner or outer flaps may open so that an edge regionof the flap face is fully parallel with the direction of current flow,at least within the range of normal inspiratory airflows. At extremelyhigh flow rates this may not hold, particularly at non-physiologicalflow rates.

In FIGS. 15A and 15B, a four-flap (a four-pie) valve example has beenmodified by including an additional “T” shaped cut along the center ofthe valve. As a result, these “T” cut regions will form adjacent flapsthat open slightly to stiffen the larger flap region (the quarterpie-shaped region), preventing it from aligning an edge region of theflap face with the direction of airflow. This is illustrated in FIG.15B. The noise-reduction performance for this type of valve may beimproved by locating the slit forming the top of the “T” further thanhalfway up the flap from the attachment site of the quarter pie-shapedflap. In general, the further up the flap this cross-slit is located,the greater the stiffness preventing the quarter pie-shaped flap fromopening so that an end face is aligned with the direction of airflow.

In some variations, the noise-reduction flap valve comprises a flexibleflap having a durometer (or a durometer and thickness) that is highenough to reduce noise during the range of air flow past the flap thatis experienced during inhalation through the device. The durometer of amaterial is a measure of the ‘hardness’ or ‘stiffness’ of the material.In general, higher durometer materials (e.g., higher than about 40 ShoreA, higher than about 45 Shore A, higher than about 50 Shore A, etc.)were believed to increase the noise of operation of the device, and inparticular, higher durometer (stiffer) materials were expected to makenoises upon closing. Surprisingly, experiments examining the noiseresulting from similarly structured flaps with different thicknesses anddurometer revealed that higher durometer materials were morenoise-reducing than lower durometer materials. In particular, thecombination of thickness and durometer of the materials was found tocontribute to noise-reduction in these experiments. In general, flapswithin the range of 2 mil to 5 mil having a higher durometer (greaterthan 40, e.g., 50) were quieter than flaps having a lower durometer. Forexample, flaps having a thickness of greater than about 2 mil (e.g., 2mil, 3 mil, 4 mil) and flaps having a durometer of greater than 40(e.g., greater than 45, greater than 50) were more noise-reducing. Inparticular, flaps having a thickness of between about 3 mil to 5 mil anda durometer of about 50 or higher were surprisingly less noisy thanflaps having a lower durometer. In addition to helping reduce the soundof closing of the flap valve (which may produce a ‘clicking’ noise uponswitching between inhalation and exhalation), the higher durometer flapsdescribed herein may also reduce noise due to oscillation. Thus flapswithin the above-described range of durometers and thicknesses may beconsidered noise-reduced flap valves.

The noise-reduction flap valves described herein may also be used inconjunction with the noise-reduction elements described herein. Forexample, a conical noise-reduction element may be used with anoise-reduction flap valve, as illustrated in FIG. 17. FIG. 17 shows across-section through a noise-reduced device including a noise-reductionflap valve 1703 that is similar to the butterfly flap valve illustratedin FIGS. 12A and 12B, above. A noise-reducing cone 1707 is alsoincluded, which can help prevent the edge of the flap(s) fromoscillating. Airflow through the device is indicated by arrows 1705.

In addition to the noise-reduction elements and noise-reducing valvesshown and described above, a noise-reducing feature may also dampen theoscillation of the edge of the flap. For example, the edge of the flapmay be thickened or stiffened compared to other regions of the flap. Anincreased stiffness in the flap, and particularly the edge region, maydampen the oscillation of the flap without substantially changing theairflow through the device. For example, a device in which the edgeportion of the flap is thicker than other portions of the flap maydampen oscillations. In another variation, the edge portion may be linedwith a material having a different stiffness (e.g., a different modulusof elasticity).

FIGS. 18 and 20 illustrate proposed methods for assembling noise-reducednasal devices. For example, FIG. 18 shows an exploded view of anoise-reduced nasal device including a noise-reduction element 1801. Inthis example, the noise-reduction element may be any of the elementsdescribed herein, including those shown in FIGS. 19A-19C. FIGS. 19A-19Cshows three exemplary noise-reduction elements, including a cage 1901, aribbed cone 1905, and a protrusion that is configured as two ribs 1903.In FIG. 18, the noise-reduction element 1801 may be attached on theproximal side of the device (the side to be inserted into the nostril inthis example). The noise-reduction element 1801 may be attached by anyappropriate method. For example, the noise-reduction element 1801 may beattached with an adhesive to a portion of the adhesive holdfast 1803,1811 which includes an opening or passageway in which the airflowresistor is attached. The airflow resistor in this example is formedfrom a flap valve 1805 and a flap valve limiter 1807. An annularattachment ring or substrate 1811 is also used to attach to (and/orpartially form) the adhesive holdfast which may secure the airflowresistor in place. The airflow resistor may include a noise-reductionflap valve as the flap valve 1805.

FIG. 20 shows an exploded view of another variation of a nose-reducednasal device including a noise-reduction flap valve 2007. This figure isvery similar to FIG. 2B except that the flap layer 207 of FIG. 2B hasbeen replaced with the noise-reduction flap valve 2007. As mentionedabove with reference to FIG., 17, additional noise-reduction elementsmay also be included. The devices may be assembled in any appropriateorder, using appropriate manufacture techniques, to form the nasaldevices. For example, the devices may be manually or automaticallyassembled.

Noise-reduced nasal devices may be worn to treat any disorder that wouldbenefit from the use of a nasal device, including but not limited torespiratory or sleeping disorders, such as snoring, sleep apnea(obstructive, central, mixed and complex), COPD, cystic fibrosis and thelike. Noise-reduced nasal device may be particularly beneficial fortreatments in which the subject is encouraged or permitted to sleepwhile wearing the device, because they may prevent potentiallydisrupting noise. The noise-reducing features of these nasal devices maydecrease the noise of operation of the nasal device by preventing theflap valve from oscillating during operation of the device (particularlyduring inhalation). To use the noise-reduced nasal device, it is firstplaced in communication with the subject's nasal cavity so that airflowfrom the subject's nose passes through the device as it is worn. Thenoise-reducing feature (e.g., a noise-reduction flap valve and/or anoise-reduction element) may then prevent or eliminate noise by limitingoscillation of the flap during inhalation and/or exhalation through thedevice. The nasal device may be placed in communication with the nasalpassageway by placing it into or at least partially over or around thesubject's nasal cavity. For example, an adhesive holdfast attached tothe nasal device may be used to secure the device in position.

In addition to the elimination of buzzing due to oscillation of theflap, noise-reduced nasal devices may also include features or elementsto help reduce whistling or other noise arising independently of theoscillation of the flap valve. In some variations, “whistling” noise maybe reduced by minimizing or limiting the creation of turbulence as airflows through the device. For example, the surfaces of the device acrosswhich air flows (e.g., the passageway, rim body, etc.) may be smoothedor buffered to prevent whistling. The surfaces may be oriented to limitwhistling by reducing air turbulence. The sizes of openings such as theleak pathway(s) and central passageways may also be configured toprevent whistling through the device. In some variations, opening of theleak pathway (or other surfaces) is oriented in parallel with thedirection of airflow to reduce whistling by reducing the turbulent flowof air across the device. In some variations, edges exposed to airfloware smoothed or rounded to minimize turbulence. Whistling may also beminimized by reducing the perimeter length of an opening or openingsthrough which air must pass. For example, in general, air flowingthrough a hole of a given frontal area will make less noise than airflowing through 10 holes each with 1/10 of the area of the single hole,but having a cumulative perimeter of over 3 times the circumference ofthe larger hole.

Many other materials and structures may be used to achieve thenoise-reducing features described. This description is not intended tobe limited to the structures and materials mentioned, but is intended toalso encompass many other materials and structures having similarproperties. Appendix A, attached below, suggests a number ofmodifications and variations of the devices and methods alreadydescribed.

In contrast to the noise-reduced nasal devices, fluttering or vibratingnasal devices (which may or may not produce noise) may also be used. Inparticular, such devices may be configured to promote a vibration orfluttering sensation when worn, by promoting oscillation of the edgeregion of the flap face and/or tip of the flap during inhalation and orexhalation. The turbulence created by nasal devices and the resultingpressure waves may be useful for those patients requiring pulmonarytherapy or rehabilitation. For example, a nasal device that causedoscillation during exhalation (and subsequent creation of oscillatorypressure waves that may be transmitted to the smaller airways) could behelpful in the treatment of cystic fibrosis or other diseases in whichmucous clearance is important. These devices may also utilize any of thepreviously described device features which may be used to preventoscillation and noise in one direction of airflow while promotingoscillation and/or pressure waves in another direction of airflow.

For example, a method of treating a disorder (e.g., cystic fibrosis) mayinclude placing a passive-resistance nasal device in communication witha subject's nasal cavity, and oscillating the flap valve to producevibrations. For example, the device may be configured so that the flapvalve oscillates during inhalation through the nasal device. The nasaldevices described herein may also be referred to as “passive-resistance”nasal devices because they do not require the active application of airpressure (e.g., blowing or pumping air or suctioning or removing air)from the subject. In some variations the devices are configured tooscillate during inhalation by orienting a flap (e.g., the flap valve)in parallel with the direction of airflow during inhalation. The devicesmay be configured to include a vibratable member (e.g., a membrane) inaddition to the flap valve that is oriented so that an edge region isroughly parallel to the direction of airflow through the device. In somevariations, the devices may be configured to oscillate or vibrate duringexhalation as well as, or instead of, during inhalation.

Although the nasal devices described herein are configured so that (innormal operation) the resistance through the device is greater duringexhalation than during inhalation, other configurations may also be usedwith the noise-reduced devices or features described herein. Forexample, a nasal device may be configured with an airflow resistor thatinhibits inhalation more than exhalation, which may be used with anoise-reduction element or flap valve configured to inhibit oscillationof the flap (or flaps) during exhalation instead (or in addition to)inhalation. In general a noise-reduced nasal device may limit theoscillation of the flap during both inhalation and exhalation. While themethods and devices have been described in some detail here by way ofillustration and example, such illustration and example is for purposesof clarity of understanding only. It will be readily apparent to thoseof ordinary skill in the art in light of the teachings herein thatcertain changes and modifications may be made thereto without departingfrom the spirit and scope of the invention.

1. A noise-reduced nasal respiratory device comprising: a noise-reducedairflow resistor comprising a flap valve, wherein the noise-reducedairflow resistor is configured to inhibit exhalation more thaninhalation and to inhibit oscillation of a free edge of the flap valveduring inhalation when the flow rate is between about 20 and 750 ml/sec;and a holdfast configured to secure the noise-reduced nasal respiratorydevice in communication with the subject's nasal cavity.
 2. The deviceof claim 1, wherein the noise-reduced airflow resistor comprises anoise-reduction flap valve.
 3. The device of claim 1, wherein thenoise-reduced airflow resistor comprises a noise-reduction elementconfigured to limit oscillation of the flap valve.
 4. The device ofclaim 2, wherein the noise-reduction flap valve comprises abutterfly-type flap valve.
 5. The device of claim 2, wherein thenoise-reduction flap valve comprises a plurality of cuts arranged sothat the edge of the flap valve does not orient substantially inparallel with the direction of airflow through the valve duringinhalation.
 6. The device of claim 2, wherein the noise-reduction flapvalve comprises a first flap and a second flap wherein the first andsecond flaps are configured to open during inhalation so that theopening of the second flap inhibits the first flap from opening inparallel with the direction of airflow through the valve duringinhalation.
 7. The device of claim 2, wherein the noise-reduction flapcomprises a dampened edge.
 8. The device of claim 2, wherein the flap ofthe noise-reduction flap valve comprises a material having a durometerthat is greater than 40 Shore A.
 9. The device of claim 2, wherein theflap of the noise-reduction flap valve comprises a material having adurometer that is greater than 40 Shore A and a thickness between about2 mil and about 5 mil.
 10. The device of claim 3, wherein thenoise-reduction element comprises a projecting surface that communicateswith the flap valve to prevent an edge of the flap valve form orientingsubstantially in parallel with the direction of airflow through thenasal device during inhalation.
 11. The device of claim 10, wherein theprojecting surface comprises a rib extending at least partially acrossan opening through the nasal device, wherein the noise-reduced airflowresistor communicates with the opening through the nasal device toincrease the resistance to air exhaled through the opening more than theresistance to air inhaled through the opening.
 12. The device of claim3, wherein the noise-reduction element comprises a cone configured toprevent an edge region of the flap valve from opening substantially inparallel with the direction of airflow during inhalation.
 13. The deviceof claim 3, wherein the noise-reduction element comprises a cone. 14.The device of claim 3, wherein the noise-reduction element comprises acastle-topped cone.
 15. The device of claim 3, wherein thenoise-reduction element comprises a cage.
 16. The device of claim 3,wherein the noise-reduction element comprises a spacer configured toprevent the edge region of the flap valve from opening in parallel withthe direction of airflow during inhalation.
 17. The device of claim 3,wherein the noise-reduction element does not substantially increase theinspiratory resistance.
 18. The device of claim 1 further comprising aleak pathway configured to remain open during both inhalation andexhalation.
 19. The device of claims 1, wherein the holdfast comprises acompressible holdfast
 20. The device of claim 1, wherein the holdfastcomprises an adhesive holdfast.
 21. The device of claim 1, wherein thenasal respiratory device has a resistance to exhalation that is betweenabout 0.01 and about 0.25 cm H₂O/(ml/sec) when measured at 100 mil/s.22. A noise-reduced nasal respiratory device comprising: a noise-reducedairflow resistor comprising a noise-reduction flap valve that isconfigured to inhibit exhalation more than inhalation, wherein thenoise-reduction flap valve is further configured so that a free edgeregion of the flap valve does not orient in parallel with the directionof airflow through the flap valve during inhalation; and a holdfastconfigured to secure the device in communication with the subject'snasal cavity.
 23. The device of claim 22, wherein the noise-reductionflap valve comprises a butterfly-type flap valve.
 24. The device ofclaim 22, wherein the noise-reduction flap valve comprises a pluralityof cuts arranged so that the edge region of the flap valve does notorient substantially in parallel with the direction of airflow throughthe valve during inhalation.
 25. The device of claim 22, wherein thenoise-reduction flap valve comprises a first flap and an opposing secondflap wherein the first and second flaps are configured to open duringinhalation so that the opening of the second flap inhibits the firstflap from opening in parallel with the direction of airflow through thevalve during inhalation.
 26. The device of claim 22, wherein thenoise-reduction flap comprises a dampened edge.
 27. The device of claim22, wherein the flap of the noise-reduction flap valve comprises amaterial having a durometer that is greater than 40 Shore A.
 28. Thedevice of claim 22, wherein the flap of the noise-reduction flap valvecomprises a material having a durometer that is greater than 40 Shore Aand a thickness between about 2 mil and about 5 mil.
 29. The device ofclaim 22 further comprising a leak pathway configured to remain openduring both inhalation and exhalation.
 30. The device of claims 22,wherein the holdfast comprises a compressible holdfast
 31. The device ofclaim 22, wherein the holdfast comprises an adhesive holdfast.
 32. Thedevice of claim 22, wherein the nasal respiratory device has aresistance to exhalation that is between about 0.01 and about 0.25 cmH₂O/(ml/sec) when measured at 100 ml/s.
 33. A noise-reduced nasalrespiratory device comprising: an opening configured to communicate withthe nasal cavity; a noise-reduced airflow resistor comprising a flapvalve in communication with the opening and a noise-reduction elementconfigured to limit oscillation of the flap valve, wherein thenoise-reduced airflow resistor is configured to increase the resistanceto air exhaled through the opening more than the resistance to airinhaled through the opening; and a holdfast configured to secure theopening in communication with the subject's nasal cavity.
 34. The deviceof claim 33, wherein the noise-reduction element comprises a projectingsurface that communicates with the noise-reduced airflow resistor toprevent an edge region of the flap valve form orienting substantially inparallel with the direction of airflow through the nasal device duringinhalation.
 35. The device of claim 34, wherein the projecting surfacecomprises a rib extending at least partially across the opening.
 36. Thedevice of claim 33, wherein the noise-reduction element comprises acone.
 37. The device of claim 33, wherein the noise-reduction elementcomprises a cone having at least one cut-out region for air passagealong the perimeter.
 38. The device of claim 33, wherein thenoise-reduction element comprises a castle-topped cone.
 39. The deviceof claim 33, wherein the noise-reduction element comprises a cageconfigured to prevent an edge region of the flap valve from opening inparallel with the direction of airflow during inhalation.
 40. The deviceof claim 33, wherein the noise-reduction element comprises a spacerconfigured to prevent the edge region of the flap valve from opening inparallel with the direction of airflow during inhalation.
 41. The deviceof claim 33, wherein the noise-reduction element does not substantiallyincrease the inspiratory resistance.
 42. The device of claim 33 furthercomprising a leak pathway configured to remain open during bothinhalation and exhalation.
 43. The device of claims 33, wherein theholdfast comprises a compressible holdfast
 44. The device of claim 33,wherein the holdfast comprises an adhesive holdfast.
 45. The device ofclaim 33, wherein the nasal respiratory device has a resistance toexhalation that is between about 0.01 and about 0.25 cm H₂O/(ml/sec)when resistance is measured at 100 ml/s.
 46. A noise-reduced nasalrespiratory device comprising: an opening configured to communicate withthe nasal cavity; a noise-reduced airflow resistor comprising a flapvalve in communication with the opening and a noise-reduction elementconfigured to prevent an edge of the flap valve from becoming orientedsubstantially in parallel with the direction of airflow through theopening during inhalation, wherein the noise-reduced airflow resistor isconfigured to increase the resistance to air exhaled through the openingmore than the resistance to air inhaled through the opening; and aholdfast configured to secure the opening in communication with thesubject's nasal cavity.
 47. A method of decreasing the noise ofoperation of a nasal device having a flap valve airflow resistor, themethod comprising: placing a nasal device in communication with asubject's nasal cavity, wherein the device includes a flap valve airflowresistor configured to inhibit exhalation more than inhalation; andlimiting the oscillation of the flap valve during inhalation through thenasal device.
 48. The method of claim 47, wherein the step of limitingthe oscillation of the flap valve comprises preventing an edge region ofthe flap valve from orienting substantially in parallel with thedirection of inspiratory airflow through the nasal device.
 49. Themethod of claim 47, further comprising preventing the flap valve fromoscillating by limiting the motion of a free end of the flap valve. 50.The method of claim 47, further comprising adhesively securing the nasaldevice at least partly over the subject's nasal cavity.
 51. A method ofdecreasing the noise of operation of a nasal device, the methodcomprising: placing a nasal device in communication with a subject'snasal cavity, wherein the device includes an opening, a flap valveairflow resistor in communication with the opening, and anoise-reduction element, wherein the flap valve airflow resistor isconfigured to inhibit exhalation more than inhalation; and inhibitingthe oscillation of the flap valve during inhalation through the nasaldevice by contacting at least a portion of a free edge of the flap valveto the noise-reduction element during inhalation.
 52. A method oftreating a disorder, the method comprising: placing a passive resistancenasal device in communication with a subject's nasal cavity, wherein thedevice includes an opening, a flap valve airflow resistor incommunication with the opening, wherein the flap valve airflow resistoris configured to inhibit exhalation more than inhalation; and vibratingthe flap valve during inhalation through the nasal device.
 53. Themethod of claim 52, wherein the disorder is cystic fibrosis.